Saturday, September 27, 2008

Profess finally published


Sacco RL et al. NEJM 359:1238-1251 2008
Yusuf et al IBID 1225-1237 2008
editorial DM Kent and DE Thaler IBID 1287-88

Aggrenox v. clopidogrel (Sacco et al.) As a neurologist not a statistician I will cut to the chase. They studied over 20,000 patients in a double blind 2x2 factorial design, randomly assigned to aggrenox or plavix. There was not evidence of the trial meeting the predefined criteria for noninferiority and there was no evidence that either treatment was superior to the other in the prevention of recurrent stroke.

Telmisartan to prevent recurrent stroke and cardiovascular events (Yusuf paper). Same 20,332 patients were randominzed to telmisartan 80 mg/day v. placebo. Interval to randomize was 15 days. Therapy continued 2.5 years . There was no evidence that therapy with telmasartan lowered the rate of recurrent stroke, major cardiovascular events or diabetes.

Editorial note.(Kent and Thaler). titled "Insights from Incoherence" authors properly note the tendency of some to make indirect comparisons based on different clinical trials (showing a better effect of aggrenox in this case) were mistaken. They also properly note that the "compelling logic of the transitive property, so reliable in mathematics, has little authority in the often illogical world of clinical trials" (I love it, but credit goes in a cite to Baker and Kramer). However Kent and Thaler liken the result to the Zen koan, a result incomprehensible to rational understanding, the contemplation of which may lead to a deeper realization. They summarize realization with the original haiku "For stroke prevention/use an antiplatelet drug/Treat hypertension."

Robert Frost, look out!

No comments: